Managing Viedoc eTMF

  • Published by Viedoc System 2024-11-14
  • Print

Mapping user roles

In Viedoc eTMF, the end user roles and permissions determine what kind of access a user has to artifact data (no access/read/write/review) on the different levels:

  • Study
  • Country
  • Site

eTMF permissions can be assigned to users to give them special access or perform certain tasks.

To map the Viedoc study roles to eTMF roles and/or permissions:

1

In Viedoc Admin, click Show studies to open the study overview page:
2

Click the eTMF settings button:
3

In the eTMF roles mapping area, select the eTMF role(s) and/or permission(s) that you want to map to the Viedoc study roles:


The Viedoc study roles correspond to the Clinic roles for the study. The eTMF permissions are defined in Viedoc. The eTMF roles correspond to the roles specified in the eTMF template file. You can map a study role to one or several eTMF roles.

The available eTMF roles are:

  • Site staff
  • Sponsor study
  • Sponsor country
  • Sponsor site
  • Reviewer
  • Sponsor Data Manager
  • Sponsor unblinded

The respective permissions for these eTMF roles are specified in the Excel template file, on the Role sheets. For more information, see Customizing a template.

The available eTMF permissions are:

  • Archive sponsor TMF
  • Archive investigator TMF
  • Read-only TMF Admin
  • Read-only Trial Master File
  • Download audit trail
  • Manage drop zone
  • Manage document sharing for Viedoc Clinic users
  • Manage document sharing for Viedoc Me users

For more information, see eTMF Permissions.
4 Click Save changes.

Enabling Viedoc eTMF for your trial

If your Viedoc license includes the Viedoc eTMF application, and if you have been assigned the role eTMF Manager, you can enable Viedoc eTMF for your trial.

To enable Viedoc eTMF:

1

In Viedoc Admin, click Show studies to open the study overview page:
2

Click the eTMF settings button:
3

To enable Viedoc eTMF for your study, toggle the Enable switch to ON in the eTMF settings dialog:

Launching Viedoc eTMF in Admin mode

Before you launch Viedoc eTMF for the first time, you need to enable it and map the Viedoc study roles to the eTMF role(s) in Viedoc Admin. When Viedoc eTMF has been enabled, you can launch it.

To launch Viedoc eTMF in Admin mode:

1

In Viedoc Admin, click Show studies to open the study overview page:
2

Click the eTMF settings button:
3

Click Launch Study eTMF:
4

When you launch Viedoc eTMF for the first time, this message is displayed:

Alternatively, if you have a Clinic role in the study, to launch Viedoc eTMF:

1

Click the eTMF icon on the Viedoc landing page:


Note! The eTMF icon is only available in Production mode.
2

When the eTMF application opens, you might need to switch to the TMF Admin view:

Locking/unlocking the eTMF

Introduction

When the eTMF is ready to be archived, an eTMF Manager can lock the eTMF.

The eTMF can be considered complete and ready for archiving when all the documents are available, reviewed, and finalized, and no more documents are to be added to the study.

When the eTMF is locked, it is available to users who have access to it in read-only mode. This means that documents can still be viewed by users who have access to them according to their roles and permissions. It is still possible to grant users access to the eTMF. However, no changes can be made to the documents, nor to the eTMF structure, templates, or settings.

Users who have access to the eTMF Archive can still generate the eTMF-EMS repository and the complete audit trail report.

When the eTMF is locked, an information message is visible in all the views to indicate that the system is locked and available in read-only mode:

  • In the TMF Admin view:
  • In the Trial Master File view:
  • In the TMF Archive view:

The status of the eTMF is shown on the Status tab in TMF Admin, and it can be one of the following:

  • Enabled
 The eTMF is enabled but no structure is instantiated yet.
  • Instantiated
 The eTMF is enabled and there is an instantiated structure. Users who have access to the eTMF can work according to their roles and permissions.
  • Locked
 The eTMF is locked and available for users in read-only mode. Users with permissions to the TMF Archive view can generate and download the TMF-EMS repository and the complete audit trail report.

Note! It is possible to unlock a locked eTMF and then lock it again.

For traceability purposes, all lock and unlock actions are audit trailed and available in the complete audit trail report. You can generate and download the report from the TMF Archive view.

Locking the eTMF

Note! The eTMF can only be locked by an eTMF Manager.

To lock the eTMF:

1 Launch the eTMF and navigate to the TMF Admin view.
2

Navigate to the Status tab.

This tab shows the TMF status and provides the possibility to lock/unlock the study eTMF.
3

Click the Lock eTMF button.
4

A dialog opens. Enter a reason for locking the eTMF and confirm.
5

The status of the eTMF changes to Locked, and information about when the system was locked and by whom is displayed on the Status tab.

Unlocking the eTMF

Note! The eTMF can only be unlocked by an eTMF Manager.

To unlock the eTMF:

1 Launch the eTMF and navigate to the TMF Admin view.
2

Navigate to the Status tab.

This tab shows the TMF status and provides the possibility to lock/unlock the study eTMF.
3

Click the Unlock eTMF button.
4

A dialog opens. Enter a reason for unlocking the eTMF and confirm.
5

The status of the eTMF changes to the status it had before locking it.